Effect of Left Paratracheal Pressure on Cerebral Oxygenation During General Anesthesia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorClinique Saint-Luc

About this trial

Left paratracheal pressure (LPP) has been proposed as an alternative to cricoid pressure to reduce the risk of regurgitation during induction of general anesthesia. Previous studies suggest that LPP can effectively compress the esophagus without significantly reducing left carotid blood flow. However, its effect on cerebral oxygenation has not yet been evaluated.

The aim of this prospective randomized crossover study is to assess whether application of LPP affects regional cerebral oxygen saturation measured by near-infrared spectroscopy (NIRS) during general anesthesia.

Seventy adult patients undergoing elective surgery under general anesthesia with tracheal intubation will be included. After induction of anesthesia and stabilization, cerebral oxygen saturation will be continuously measured under three conditions: no cervical pressure, left paratracheal pressure at 30 N, and cricoid pressure at 30 N. The order of the two pressure maneuvers will be randomized.

The primary objective is to determine the change in left regional cerebral oxygen saturation during LPP compared with baseline without cervical pressure.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥18 years

Scheduled for elective surgery requiring general anesthesia with orotracheal intubation

American Society of Anesthesiologists (ASA) physical status I to III

Ability to understand the study information

Disqualifiers

Refusal to participate

Known or suspected pregnancy

Emergency surgery

Inability to provide informed consent

Trial design

Design model

Crossover

Treatments tested in this trial

  • Left Paratracheal Pressure

    Procedure/Surgery

    A standardized cricoid pressure of 30 N will be applied for 45 seconds using a calibrated force-measuring device. Regional cerebral oxygen saturation, hemodynamic variables, and respiratory variables will be continuously recorded during the intervention.

  • Cricoid Pressure

    Procedure/Surgery

    A standardized cricoid pressure of 30 N will be applied for 45 seconds using a calibrated force-measuring device. Regional cerebral oxygen saturation, hemodynamic variables, and respiratory variables will be continuously recorded during the intervention.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: LPP then CPExperimental treatment 2 interventions
Group B: CP then LPPExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum Change in Left Regional Cerebral Oxygen Saturation During Left Paratracheal Pressure

Maximum absolute change in left regional cerebral oxygen saturation (rSO2), expressed in percentage points, during application of left paratracheal pressure at 30 N compared with the baseline value obtained without cervical pressure.

Time frame
During the 45-second application of left paratracheal pressure, compared with the preceding baseline period

Secondary outcomes

1

Maximum Change in Right Regional Cerebral Oxygen Saturation

Maximum absolute change in right regional cerebral oxygen saturation (rSO2), expressed in percentage points, during application of each cervical pressure maneuver compared with the baseline value obtained without cervical pressure.

Time frame
During each 45-second cervical pressure intervention, compared with the preceding baseline period
2

Difference in Change in Left Regional Cerebral Oxygen Saturation Between LPP and Cricoid Pressure

Within-participant difference in the maximum absolute change in left regional cerebral oxygen saturation (rSO2), expressed in percentage points, between left paratracheal pressure at 30 N and cricoid pressure at 30 N.

Time frame
During the two 45-second cervical pressure interventions
3

Difference in Regional Cerebral Oxygen Saturation Between the Left and Right Hemispheres

Difference in regional cerebral oxygen saturation (rSO2), expressed in percentage points, between the left and right cerebral hemispheres during baseline, left paratracheal pressure, and cricoid pressure.

Time frame
During baseline and each 45-second cervical pressure intervention
4

Change in Mean Arterial Pressure

Change in mean arterial pressure (MAP), measured in mmHg, during left paratracheal pressure and cricoid pressure compared with baseline.

Time frame
During baseline and each 60-second cervical pressure intervention

Other outcomes

Sponsors and contacts

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